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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Lung Cancer

Phase 3
Waitlist Available
Led By Vassiliki Papadimitrakopoulou
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity
Patients must not have had prior treatment with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing nivolumab with or without ipilimumab to see if it can treat patients with squamous cell lung cancer that has come back after previous treatment.

Who is the study for?
This trial is for patients with stage IV squamous cell lung cancer that has returned after treatment. Participants must not have allergies to nivolumab or ipilimumab, no recent steroids or immunosuppressants, no HIV/AIDS, and should be free of certain heart conditions. They can't have had prior treatments targeting immune checkpoints and must not suffer from active autoimmune diseases.
What is being tested?
The study compares the effectiveness of two monoclonal antibodies: nivolumab alone versus nivolumab combined with ipilimumab in treating recurrent lung cancer. It's a phase III trial for those who didn't qualify for other biomarker-driven studies.
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in various organs, potential lung issues (pneumonitis), skin reactions, hormone gland problems (like thyroid dysfunction), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have lung disease that causes symptoms or could affect lung toxicity treatment.
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I have not received treatments targeting immune checkpoints.
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I am not allergic to nivolumab or ipilimumab.
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I do not have HIV or AIDS.
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I do not have severe heart disease or recent serious heart issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Investigator-assessed Progression-free Survival (IA-PFS)
Pharmaceutical Preparations
Objective Response Rate
Other study objectives
Screen success rate
Treatment arm randomization acceptance rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nivolumab, ipilimumab)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (nivolumab)Active Control4 Interventions
Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
396 Previous Clinical Trials
265,177 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,912 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,662 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02785952 — Phase 3
Lung Cancer Research Study Groups: Arm II (nivolumab), Arm I (nivolumab, ipilimumab)
Lung Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02785952 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02785952 — Phase 3
~28 spots leftby Oct 2025
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